Remote Senior Study Start Up Specialist (m/w/d)

** Please do not apply if you are not fully elibigle to work in Spain. CTI does not offer any Sponsorship **

Job Purpose/Summary:

Provide advises on clinical studies submission strategy in Europe and responsible for development of EU Regulatory Clinical Trial Submission Plan. Interact with, assist, and advise the countries teams, sponsors, and CTI management to facilitate timely collection, assessment and processing of essential regulatory documentation for study submission. Proceed with Clinical Trials submission across Europe, namely using EU submission portal (CTIS) and/or other Regulatory Bodies.

Maintain essential regulatory documentation for multiple studies and perform review, reconciliation, close-out and archiving activities of study or project documentation according to CTI or Sponsor SOPs.

Essential Functions:

• Assist/advise project teams on all regulatory requirements for clinical studies
• Discuss studies submission strategies, in EU, with CTI Project Management Teams and Sponsors, in accordance with Clinical Trial Regulation 536/2014
• Develop and discuss EU Regulatory Clinical Trial Submission Plan with CTI study management team and the Sponsor.
• Perform compliance assessments according to Member State Concerned (MSC) requirements and document any activity discovered; notify Project Managers of any findings.
• Review and adapt study specific documents according to each MSC and site requirements.
• Receive and process study documentation from sites and sponsors, check content and quality as well as completeness
• Interact with site personnel, CPCs, CRAs and PMs, for document corrections, clarification or resolution of any incomplete and/or incorrect documentation found during document content quality review.
• Compile Regulatory documentation according to CTI SOPs, sponsor SOPs and applicable MSC requirements, perform a QC review of all documentation before submitting in CTIS and/or other Regulatory Bodies according to the local requirements.
• Adapt Informed Consent Form (ICF) according to each MSC requirements.
• Preparation, quality check and filing of MSC adapted ICF according to local requirements
• Perform submissions via EU portal (CTIS Part I and Part II) or other Regulatory Bodies on behalf of sponsors and in accordance with Clinical Trial Regulation 536/2014
• Interact with Sponsors as needed; forward regulatory documentation, including final regulatory submission packages, if requested, to Sponsor in accordance with CTI or Sponsor SOPs
• Respond to request for information (RFI) via CTIS and/ or other Regulatory Bodies in liaison with sponsor and study PM or assist sites in their response to IRB according to Member State Concerned and site requirements
• Compiling and assessing completeness of the Regulatory-Package for drug release (Regulatory Document Study Start Up Checklist)
• Provide Project teams with accurate periodic status reports in accordance with CTI SOPs and attend internal and external project meetings as needed.
• Accurately apply naming conventions, upload, and process all correct and complete study documentation in the study start-up module or trackers and study specific TMF system whether electronic or paper
• Perform review, reconciliation, close-out, and archiving activities of study or project documentation according to CTI SOPs or sponsor SOPs
• Independently prepare for Sponsor or Agency audits and inspections
• Oversee translation of regulatory documents, if needed, on behalf of Sponsor, as agreed to in scope

Required Education / Experience:

• Associate’s or Bachelor’s Degree in allied health field such as nursing, pharmacy or health science or the equivalent relevant experience
• A minimum of 5 years of relevant pharmaceutical, site, or CRO Regulatory experience
• Experience in Studies Clinical Trials Submissions in several EU countries, preferably via CTIS

Competencies:

• Ongoing willingness to learn
• Detail oriented
• Ability to collaborate well in a team environment
• Ability to maintain confidentiality
• Proficient in use of computer and software systems
• Excellent verbal and written communication skills
• Fluent in oral and written English is a must, good Spanish language skills are also needed
• Ability to provide superior level of customer service
• Ability to develop, prioritize, organize, and manage multiple tasks
• Decision making and creative problem-solving skills
• Working knowledge and understanding of applicable Member State Concerned regulations, International Council on Harmonization (ICH) / Good Clinical Practice (GCP) regulations and guidelines

Why CTI?

• Advance Your Career – We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. We also value ongoing education and training through a dedicated training department.
• Join an Award-Winning and Valued Team – We have an award-winning unparalleled culture that can be felt by our employees across 60 countries. We support a work-life balance and the importance of time with family by offering hybrid work from home opportunities. We also encourage care for the world around us through our unique CTI Cares program.
• Make a Lasting Impact – We focus on moving medicine forward by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market.